MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INJECTION GOLD PROBE; UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	M00560150
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a0501 captures the reportable event of distal tip detachment of device or device component.
Event or Problem Description
It was reported to boston scientific corporation that an injection gold probe was used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2025.During procedure, the entire distal gold tip detached from the end of the catheter and fell into the patient.Another injection gold probe was used to complete the procedure.Bleeding was reported but per the physician's opinion, device or procedure did not contribute to the complication.
Event or Problem Description
It was reported to boston scientific corporation that an injection gold probe was used during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2025.During procedure, the entire distal gold tip detached from the end of the catheter and fell into the patient.Another injection gold probe was used to complete the procedure.Bleeding was reported but per the physician's opinion, device or procedure did not contribute to the complication.
Additional Manufacturer Narrative
Block h6: device code a0501 captures the reportable event of distal tip detachment of device or device component.Block h11: the returned injection gold probe was analyzed.Visual and microscope inspection found the gold tip was not detached but broken.There was a fragment of the ceramic tip still attached to the catheter.The broken section was not return.The customer provided a blurry picture where it was possible to observe the ceramic tip was missing.The reported event of distal tip detachment of device or device component was not confirmed.Based on all available information, it is most likely that procedural or anatomical factors encountered during the use of the device could have affected the device performance and integrity.This could have been generated if there was contact between the device, and the scope or any hard surface.Therefore, the most probable root cause is adverse event related to procedure since the procedure occurred during the procedure, and the device had no influence on the event.The reported issue of distal tip detachment of device or device component will be classified as "no problem detected".

• Brand Name: INJECTION GOLD PROBE
• Common Device Name: UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22677025
• Report Number: 3005099803-2025-03700
• Device Sequence Number: 15687741
• Product Code: KNS
• UDI-Device Identifier: 08714729056492
• UDI-Public: (01)08714729056492(17)260528(10)34122980
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133933
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2026
• Device Model Number: M00560150
• Device Catalogue Number: M00560150
• Device Lot Number: 0034122980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Female